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The latest from FDA
Mpox response: New draft guidance for industry
FDA announced availability of a draft guidance for industry entitled, “Mpox: Development of Drugs and Biological Products.” FDA is issuing this guidance to support sponsors in their development of drugs and biological products for mpox. This guidance provides nonclinical, virology, and clinical considerations for mpox drug and biological product development programs, with a focus on recommendations to support initiation of clinical trials. Preventive vaccines are not addressed in this guidance. Submit comments by March 21, 2023. (January 19, 2023)
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Emergency Use Authorization (EUA) updates
COVID-19 in vitro diagnostic (test) EUAs
As of January 24, 2023, 443 tests and sample collection devices are authorized by FDA under EUAs. These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 59 antigen tests, and 1 diagnostic breath test. There are 79 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 EUAs for molecular OTC at-home tests. FDA has authorized 44 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,217 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
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Events
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January 26, 2023: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss the future vaccination regimens addressing COVID-19, including consideration of the composition and schedule of the primary series and booster vaccinations. Watch live on YouTube, starting at 8:30 a.m. ET.
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New! February 9, 2023: FDA Grand Rounds: A Modular Approach for Enhanced Plasmid Subtyping and AMR Gene Profiling of Plasmids (webcast, 12:00 - 1:00 p.m. ET) - Plasmids are a major factor in the spread of antimicrobial resistance genes. Current plasmid typing methods do not account for the great degree of genetic diversity associated with the recombination mechanisms that allow plasmids to acquire antimicrobial resistance genes. In this presentation, Lucas Harrison, Ph.D., FDA Center for Veterinary Medicine (CVM), introduces an enhanced plasmid subtyping method that not only identifies the genetic elements exclusive to and indicative of a plasmid type, but also characterizes plasmids based on the DNA sequence and relative position of these genetic elements as they are rearranged through plasmid recombination mechanisms.
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February 15, 2023: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (COVID-19 and mpox) (12:05 - 1:00 p.m. ET) - No registration required. There will be an opportunity to ask questions live on the call, and questions may also be submitted in advance by emailing CDRHWebinars@fda.hhs.gov.
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New! February 17, 2023: Application of Artificial Intelligence and Machine Learning for Precision Medicine (virtual) - Hosted in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), this workshop will review current methodologies, opportunities, challenges, and best practices to address the rapidly changing landscape of artificial intelligence and machine learning in the setting of drug development and precision medicine. Advance registration required.
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New! April 24-28, 2023: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (Maryland or virtual) - Save the date! Registration will open in February 2023.
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Information for industry and health care providers
FDA issues guidance to help increase supply of ibuprofen oral suspension products in hospitals and health systems
FDA issued an immediately-in-effect guidance on compounding certain ibuprofen products in an effort to bolster supply of pediatric ibuprofen amid record high demand. The guidance clarifies FDA’s regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems. (January 20, 2023)
FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date.
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In case you missed it
What happens to EUAs when a public health emergency ends?
There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ.
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It's a good time to get your flu vaccine
Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu. Find a flu shot near you. (Tip: You can get your updated COVID-19 vaccine booster at the same time!)
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 350 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.
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